FDA Medical devices recall ·

Penner Pacific Bathing Spa, Model Numbers 360020-1EP recall

Recall number
Z-1501-2026
Date
(initiated August 13, 2025)
Company / brand
Penner Patient Care, Inc.
101 Grant St, Aurora, NE, United States
Category
Medical devices › Class III
Classification
Class III
Status
Ongoing
Units affected
10 units
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Penner Pacific Bathing Spa, Model Numbers 360020-1EP

Why was it recalled?

The device does not bear a unique device identifier.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI-DI: 0085007365402; Serial Numbers: 03203147501 01192957001 06203171301 07203175701 11162597701 11193074801 11193074802 09193074801 09193074802 09193074803

Distribution

US Nationwide distribution.

What does Class III mean?

Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).

Source: FDA (medical devices), recall Z-1501-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.